In an analysis published by Nature, nearly a quarter of all trials experienced setbacks due to strategic issues, commercial barriers, and operational challenges. The financial repercussions of such setbacks are significant, with drug developers facing potential losses ranging from $600,000 to $8 million per day. This statistic underscores the critical importance of effective, end-to-end clinical trial site management. If you’re a clinical research site, you know that every dollar counts. As sites strive to operate faster and more cost-effectively, the need for efficient budget management has never been more critical. From managing a single-site study to coordinating multi-site trials across geographic locations, the evolving complexities of today’s trials spotlight a tangible benefit for sites leveraging technology over those still anchored in paper-based processes. In this blog, we’ll justify the benefits of maximizing budgets in clinical trials for clinical research sites.
Understanding the Landscape
Today, clinical research sites are increasingly recognizing the benefits of consolidating their systems under a single eClinical vendor. These advanced technologies, such as Clinical Trial Management Systems (CTMS), Electronic Source (eSource), eDocs (eRegulatory), remote monitoring, participant engagement tools, and more offer a range of benefits that significantly drive the efficiency and effectiveness of clinical trials for sites, sponsors, CROs, and patients.
Before diving into the financial benefits of adopting a fully integrated site-based eClinical solution for end-to-end clinical trial management, it’s crucial to understand the current challenges facing clinical trial budgets for sites. Traditional approaches to trial management often involve disparate systems and manual processes, leading to inefficiencies, increased costs, and delays. Budget overruns are not uncommon, with factors such as protocol amendments, patient recruitment challenges, and regulatory compliance adding to the financial burden.
What are Site-Based eClinical Solutions in Clinical Trials?
A comprehensive eClinical solution, like RealTime-SOMS, a total system bundle including site technology essentials such as CTMS, eSource, eDocs, SitePay, Text, Engage! (MyStudyManager Participant Portal + eConsent), and a Mobile App, streamlines a purpose-built suite of integrated systems that simplify site operations. When sites unify disparate processes and data streams under a single, fully integrated eClinical solution, they can eliminates silos, reduce manual errors, and access real-time insights into trial performance – all of which contribute to improved clinical trial budget management for sites.
Financial Advantages of an Integrated eClinical Solution
Cost Saving & Value
Consolidating your site-based clinical trial software under one vendor offers tangible cost savings and value. By eliminating the need for multiple vendors and streamlining your site-based eClinical technology stack, you reduce overhead costs, minimize training expenses, and optimize resource allocation.
Reduced Operational Costs
One of the most significant financial benefits of a single system is the reduction of operational costs. By automating repetitive tasks, such as data entry and reconciliation, these platforms minimize the need for manual labor, freeing up resources that can be allocated to other critical activities. Moreover, centralized data management and streamlined workflows result in fewer protocol deviations and query resolutions, further driving down operational expenses.
Faster Study Start-Up
eClinical technology excels at expediting study start-up timelines. With features like task management, mobile accessibility, audit trails, comprehensive document management, and instant notifications, these platforms foster unparalleled communication and collaboration among all stakeholders involved in clinical trials, including sponsors, investigators, patients, and regulatory bodies. This cohesive integration ensures that organizations can initiate trials sooner, effectively reducing start-up times, curtailing potential delays, and unlocking greater revenue opportunities. Altogether, the adoption of the best-in-class site-based eClinical platform is a strategic move towards optimizing trial efficiency and maximizing the financial potential of clinical research studies.
Additional Benefits of an Integrated Site-based eClinical Solution
Data Integration & Interoperability
Interoperability refers to the ability of different systems and devices to communicate and work together seamlessly. eClinical solutions like eRegulatory and eSource (Electronic Source) provide flexible binder structures, alerts and reports, automated workflows, and secure role-based access. Altogether, these capabilitites drive greater efficienties and confidence in managing clinical trials. Consolidating your tech stack enhances interoperability since solutions developed by the same vendor are designed to connect natively. Additionally, this seamless integration also ensures that data flows effortlessly between systems, minimizing manual data entry and the potential for errors that come with it.
Improved Data Quality
Another benefit of adopting an integrated eClinical system, as opposed to relying on multiple vendors or makeshift solutions like Excel sheets and non-specialized platforms, is the significant enhancement of data quality and the provision of real-time data access. Digital data collection improves the data quality for clinical research sites and leads to more cost-effective clinical trials. Furthermore, the capabilities for real-time monitoring allow sponsors to oversee site progress remotely, eliminating the need for onsite visits. This enables immediate exchange of documents and data, streamlined workflows, and facilitates remote Source Data Verification (SDV), optimizing the trial management process.
Safeguard Compliance
By consolidating site-based software under one vendor, sites can simplify compliance efforts and reduce the likelihood of compliance-related issues. eSource and eRegulatory solutions, for instance, minimize the risk of errors, discrepancies, and regulatory sanctions by assuring real-time data capture, electronic document management, and audit trail functionality. The adoption of these technologies helps in meeting rigorous data security and privacy standards, such as 21CFR11 and HIPAA compliance. These systems offer cloud-based platforms, enabling site IT staff to manage data securely while acccomodating complex configurations as needed.
Scalability, Flexibility and Growth Potential
As trial requirements evolve and expand, organizations need scalable and flexible solutions that can adapt to changing needs. Consolidating your site-based eClinical platforms under a single vendor offers scalability to accommodate studies of all sizes and complexities, from small Phase I trials to large multinational trials. Additionally, customizable and enterprise-grade deployment options provide flexibility, allowing organizations to scale resources up or down as needed without significant upfront investment or infrastructure costs. With centralized study management, automated workflows, and customizable reporting capabilities, a comprehensive system empowers clinical research sites to scale faster.
Realizing the Value
We predict the the industry will continue to embrace digital transformation, and eClinical solutions will play an increasingly pivotal role in shaping the future of clinical research. This will enable clinical research sites to operate more cost-effectively and with greater confidence than ever before. The consolidation of eClinical systems under a single vendor offers clinical research sites numerous benefits, including improved data quality, real-time study oversight, increased data integrity and compliance, improved participant engagement and retention, scalability, and cost savings. Leveraging these platforms, sites can maximize clinical trial budget efficiency and drive greater returns on investment in clinical trials. While challenges exist, careful planning, selection of the right vendor, and ongoing training and support can help sites maximize the advantages of these technologies.
The RealTime Solution
RealTime Software Solutions simplifies the research process by reducing the complexity of system logins, streamlining system implementation and training, and providing unparalleled support for over 3,000+ clinical research sites worldwide, establishing itself as a preferred technology partner in clinical research.
RealTime’s Site Operations Management System (SOMS), built by a former site owner, emerges as a comprehensive, site-based eClinical bundle solution and essential toolkit. The SOMS product suite includes CTMS, eRegulatory, eSource, Engage! (MyStudyManager™ + eConsent), SitePay, and Text. This complete, natively integrated platform empowers clinical research sites to efficiently manage all operational aspects through a total package software solution. RealTime products seamlessly integrate into a unified system, replacing error-prone paper processes. Moreover, RealTime-SOMS stands out as the only solution offering the convenience of data access via a secure mobile app.
Highlights
- Unified Login System: RealTime consolidates vendor logins into a single, secure access point, dramatically reducing the hassle of managing multiple credentials and improving operational efficiency.
- Streamlined Implementation: Our streamlined implementation process is designed to integrate seamlessly with existing workflows, minimizing downtime and ensure a smooth transition to our system.
- Consolidated Training Programs: RealTime offers a unified training program that covers all aspects of our system, eliminating the redundancy of multiple training sessions and accelerating the learning curve.
- Experienced Support Team: RealTime provides one comprehensive support team that is well-versed in all aspects of our system, offering efficient and knowledgeable assistance.
- Best-in-Class Innovation: RealTime is committed to innovation, continuously updating our system with the latest technology to meet the changing landscape of clinical research. This commitment ensures our clients are always at the forefront of research capabilities.
- Dedicated Migration Team: For clients transitioning from Clinical Conductor or other systems, RealTime offers an expert migration team. This team specializes in the smooth transition of data to our system, safeguarding integrity and minimizing disruption to ongoing operations.
FAQs
Q: What specific challenges do clinical research sites face in implementing eClinical solutions?
A: Clinical research sites may encounter challenges such as initial setup and configuration of the integrated platform, data migration from existing systems, staff training staff, ensuring compliance with regulatory requirements, and managing the transition process without disrupting ongoing trials.
Q: How can clinical research sites ensure successful adoption and utilization of eClinical platforms?
A: To ensure successful adoption, clinical research sites should invest in comprehensive training programs for staff, establish clear communication channels with their preferred technnology vendor, customize the platform to meet specific workflow needs, conduct thorough testing before full implementation, and establish ongoing support and feedback mechanisms.
Q: What considerations should clinical research sites keep in mind when selecting a technology vendor?
A: Clinical research sites should consider factors such as the vendor’s track record and reputation in the industry, the comprehensiveness and scalability of their integrated platform, compatibility with existing systems, customer support and training services, data security measures, and cost-effectiveness.
Q: Is there an eClinical solution that can accommodate the diverse range of clinical trials conducted by clinical research sites, including varying therapeutic areas and study designs?
A: Yes. RealTime’s product suite is designed to be flexible and customizable to accommodate the diverse needs of clinical research sites and the wide range of trials they conduct. Whether it’s a Phase I oncology trial or a large-scale multicenter study in cardiology, RealTime’s eClinical platform can adapt to different therapeutic areas, study designs, and regulatory requirements.
About RealTime Software Solutions
RealTime Software Solutions, LLC stands at the forefront of the industry as a premier provider of cutting-edge eClinical solutions tailored to the needs of clinical research sites, site networks, sponsors, and CROs. Our comprehensive suite of products includes the Clinical Trial Management System (CTMS), eRegulatory document management (eDocs), electronic data capture for source documents (eSource), participant payments (SitePay/GlobalPay), participant engagement solutions (Text, eConsent, and MyStudyManager™ Participant Portal), Complion eRegulatory/eISF, and Devana for pipeline management, study start-up, and business intelligence.
With a proven track record of empowering research organizations, we are committed to delivering innovative, user-friendly interfaces that redefine clinical research for clinical trials. Through our solutions, we aim to revolutionize how research is conducted, providing unparalleled efficiency and effectiveness at every stage of the process.
